We are seeking a Laboratory Quality Manager for a 2-year-regular position (renewable) to work within the Quality Management unit at the International Vaccine Institute in Seoul, Korea. (Duty station : Seoul, Korea)
This job is responsible for ensuring that all laboratory research (including clinical trials, manufacturing technology development and observational studies) sponsored or supported by IVI and laboratory areas (e.g. GCLP, Biorepository, Immunology, etc.) comply with the IVI Quality Policy, relevant regulatory requirements, standards, guidelines and IVI controlled documents. This will involve overseeing laboratory quality efforts in concert with and support of the overall IVI Quality Management organization, requiring effective and co-operative interaction with IVI staff and external consultants and stakeholders.
Key Roles & Responsibilities
1. Quality Management system development
- Support the development/periodic review of Laboratory Quality Management systems and relevant documents(including controlled documents)
- Update and maintain documents needed for the Laboratory Quality, e., controlled documents that support the Quality Management system
- Maintain working knowledge of current applicable guidelines and regulations related to laboratory practices (e.g. GLP, GCLP) the conduct of research, and the principles and methods related to quality management
- Report proposed changes to policies & procedures to the IVI Quality Standards Committee for consideration and to QM for approval, implementation and management.
2. Quality Assurance/Quality Control
- Develop QA/QC activities plan and other relevant documents laboratory wide and for each individual project in which IVI assumes a sponsor or collaborator role to ensure all laboratory and supported clinical activities are in line with IVI quality policies, regulatory requirements, standards and guidelines.
- Prior to the start of a laboratory project (e.g., laboratory assay development, manufacturing, clinical trial or observational study), review supporting documents to ensure compliance with IVI Quality Policy, IVI controlled documents, regulatory requirements, standards and guidelines.
- Ensure that data are recorded and analyzed in accordance with the protocols, methods and
- Ensure proper maintenance of all laboratory, clinical and organizational-level SOPs, as well as clinical documentation databases and systems in accordance with relevant standards, e.g., Trial Master Files, LIMS data and configuration, GxP documents
- Plan and conduct internal process audits and external site audits as needed to ensure ongoing compliance with IVI controlled documents, supporting documents (e.g., study protocols, methods, GCLP requirements, etc.) and regulatory requirements
- Lead periodic controlled document review/approval process for laboratory areas and those controlled documents linked to other departmental procedures.
- Advise IVI stakeholders in evaluating laboratory vendors, laboratory areas and feasibility and performance of audited entities.
3. Quality Improvement
- Develop and share reports on QA/QC activities, internal/external audit results detailing key observations and Corrective and Preventive actions (CAPA).
- Implement CAPA plans for any deficiencies identified external to an audit or audit observations identified/communicated by IVI stakeholders, regulatory agencies, donors or collaborators.
- Develop and provide comprehensive Clinical Quality Training, i.e., IVI policy / controlled document training, periodic GxP trainings for IVI stakeholder personnel (as required)
- Manage and configure IVI’s CLOUDLIMS system to meet QM and laboratory stakeholder requirements for system management, validation and control
- Training laboratory personnel and stakeholders as to LIMS functionality and use
- Work closely with the LIMS administrator (i.e., Document Control Specialist) to ensure industry requirements related to validated cloud-based systems are met and end-user requirements and concerns are addressed in a timely manner.
Job Requirements and Qualifications
1. Education Requirements
- Bachelor’s degree required, Master’s degree preferred
2. Related Field Work Experience
- 5+ years experience under direct line management to Quality Assurance supporting laboratory oversight.
3. Technical and Professional Skills / Knowledge
- Expert knowledge of GXP, GCLP, GLP
4. Language Proficiency
- Fluency in English (spoken and written)